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Longitudinal Care: Smoking Reduction to Aid Cessation

Primary Purpose

Chronic Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
smoking cessation
Sponsored by
National Institutes of Health (NIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Diseases focused on measuring smoking cessation, smoking reduction, nicotine replacement therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 18-80 Current and regular smoker 5 or more cigarettes per day Interested in making a quit attempt in the next 14 days Personal phone available Exclusion Criteria: Pregnancy or plans to become pregnant in the next year Cannot speak English Not a union member or employee of specified worksite or immediate family member Member of household is currently enrolled in the study Not willing to comply with study protocol

Sites / Locations

  • Minneapolis VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Longitudinal Care

Usual Care

Arm Description

One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.

Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks

Outcomes

Primary Outcome Measures

The primary endpoint will be 6M of abstinence measured 18M after enrollment.
6M prolonged abstinence

Secondary Outcome Measures

7d point prevalent abstinence
Data collected at 21d, 3, 6, 12, 18M
30d point prevalent abstinence
Data collected at 3, 6, 12, 18M
Smoking reduction
Data collected at 3, 6, 12, 18M
Total duration of abstinence
Time Line Follow Back

Full Information

First Posted
March 30, 2006
Last Updated
February 11, 2011
Sponsor
National Institutes of Health (NIH)
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00309296
Brief Title
Longitudinal Care: Smoking Reduction to Aid Cessation
Official Title
Longitudinal Care: Smoking Reduction to Aid Cessation; Part of Hatsukami's Tobacco Exposure Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health (NIH)
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether an extended care treatment model lasting over a year will increase long-term smoking cessation rates compared to the standard 8 week treatment of care.
Detailed Description
Objective The objective of this project is to conduct a randomized controlled trial to compare 1) an extended quality care smoking cessation treatment delivered over a one-year period (EQC) to 2) quality care smoking cessation treatment delivered over an 8 week period (QC) to determine if EQC improves prolonged smoking abstinence. Research Design/Methodology 500 smokers who are interested in quitting will be enrolled and randomly assigned to the EQC or QC groups. Both groups will initially receive a state-of-the-science smoking cessation intervention including behavioral and pharmacological components, delivered by a combination of in-person and telephone care. EQC participants who fail to quit, reduce but do not quit, or relapse will receive intensive treatment over the ensuing 12 months that encourages repeat quit attempts and smoking reduction if they are not to quit. We propose reduction as an intermediate goal in LC because this may increase the likelihood of cessation, increase self-efficacy and keep smokers and clinicians engaged. Reduction treatment will include behavioral treatment and nicotine replacement. QC participants will only receive occasional prompts to quit. The primary endpoint will be 6M of abstinence measured 18M after enrollment. Secondary endpoints will include point prevalent abstinence, smoking reduction, self-efficacy and satisfaction. We will also collect qualitative data from successful abstainers and reducers about decision making processes and intervention experiences. Clinical Significance This project will address the potential role of smoking reduction in the treatment menu for smokers interested in quitting. This project examines mechanisms, methods and a "real world" application for reducing toxin exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
smoking cessation, smoking reduction, nicotine replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal Care
Arm Type
Experimental
Arm Description
One year of combined behavioral and pharamcological tobacco dependence treatment, with interim smoking reduciton for smokers who fail initial quit attempt.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Evidence based, state-of-the-science tobacco treatment; combined behavioral and pharmacological treatment for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation
Intervention Description
This was a randomized controlled trial to compare long-term smoking cessation outcomes between Longitudinal Care (LC) and Usual Care (UC) treatment groups. The LC group received smoking cessation treatment (combined behavioral and pharmacological therapies) for one-year period. This treatment recommended repeat quit attempts or smoking reduction for those who failed to quit after the initial attempt. The UC group received evidence-based treatment that lasted 8 weeks.
Primary Outcome Measure Information:
Title
The primary endpoint will be 6M of abstinence measured 18M after enrollment.
Description
6M prolonged abstinence
Time Frame
18M
Secondary Outcome Measure Information:
Title
7d point prevalent abstinence
Description
Data collected at 21d, 3, 6, 12, 18M
Time Frame
18M
Title
30d point prevalent abstinence
Description
Data collected at 3, 6, 12, 18M
Time Frame
18M
Title
Smoking reduction
Description
Data collected at 3, 6, 12, 18M
Time Frame
18M
Title
Total duration of abstinence
Description
Time Line Follow Back
Time Frame
18M

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-80 Current and regular smoker 5 or more cigarettes per day Interested in making a quit attempt in the next 14 days Personal phone available Exclusion Criteria: Pregnancy or plans to become pregnant in the next year Cannot speak English Not a union member or employee of specified worksite or immediate family member Member of household is currently enrolled in the study Not willing to comply with study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne M Joseph, MD, MPH
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VAMC
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22123795
Citation
Joseph AM, Fu SS, Lindgren B, Rothman AJ, Kodl M, Lando H, Doyle B, Hatsukami D. Chronic disease management for tobacco dependence: a randomized, controlled trial. Arch Intern Med. 2011 Nov 28;171(21):1894-900. doi: 10.1001/archinternmed.2011.500.
Results Reference
derived

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Longitudinal Care: Smoking Reduction to Aid Cessation

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